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Type 2 Diabetes clinical trials

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NCT ID: NCT04083248 Terminated - Type 2 Diabetes Clinical Trials

Building Self-regulation Capacity in AA T2DM Women: Feasibility of EMI

Start date: September 20, 2019
Phase: N/A
Study type: Interventional

In African-Americans, the incidence of type 2 diabetes (T2DM) is ~14%. Adherence to crucial diabetes self-management (DSM) behaviors, such as engaging in physical activity (PA) is dangerously low among AA women living in disadvantaged neighborhoods. These women manage numerous chronic challenges (daily discrimination, poverty, and violence), which drain the internal energy needed for DSM. The ability to self-regulate (modify one's behaviors based on the requirements of a situation) has been associated with adherence to health behaviors, including diet and PA. This 6-week ecological momentary intervention (EMI) feasibility study has been developed to reduce energy needs of DSM through use of self-regulation strategies delivered in real-time, in the real-world setting. Twenty-six AA women will receive personalized diabetes education over two days. They will be given a personalized activity prescription and a Fitbit wrist activity monitor. During the following two weeks, they will get a personal continuous glucose monitor (CGM) and individualized "cue cards" for simple behaviors they can try when glucose levels are too high. The intervention is grounded in self-regulation theory, and targets core self-regulation components, including self-monitoring/assessment, mental contrasting of target values with actual values, and goal-setting/review. The aim for this application is to Determine the feasibility and acceptability of an ecological momentary intervention, consisting of continuous glucose monitoring, activity tracking, and personalized cue cards with behavioral choices (eating/activity) driven by the results of glucose levels. Impact: Real-time feedback on the effects of activity and eating behaviors will enable patients to make choices and see results immediately. Our intervention will offer low-income African-American women opportunities to enact behaviors in their momentary environment, and will encourage autonomous motivation for PA uptake, and improving blood glucose control. Findings from this study will have an important positive impact on our ability to create tailored, EMIs among low-income adults who have limited access to diabetes specialty care and education.

NCT ID: NCT03072901 Terminated - Obesity Clinical Trials

Registry Observing EndoBarrier® Treatment Outcomes in Subjects With Type 2 Diabetes and/or Obesity

Start date: December 2010
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of the registry was to observe the safety and effectiveness outcomes for subjects treated with the EndoBarrier in the post market setting where the product had Conformité Européene (CE mark) regulatory approval and in accordance to the approved Indication For Use.

NCT ID: NCT02965443 Terminated - Type 2 Diabetes Clinical Trials

Dapagliflozin + Saxagliptin in a Basal-bolus Insulin Treatment

DapaSaxaBBIT
Start date: February 2, 2018
Phase: Phase 4
Study type: Interventional

To perform a study that investigates the effectiveness of adding the SGLT2 inhibitor dapagliflozin + the dipeptidyl peptidase 4 (DPP-4) inhibitor saxagliptin vs placebo to revert from a BBIT regimen to a BOT regimen in patients with type 2 diabetes.

NCT ID: NCT02885428 Terminated - Type 2 Diabetes Clinical Trials

Detection no Invasive of a Silent Myocardial Ischemia

Start date: April 15, 2015
Phase:
Study type: Observational

The pathophysiological features of myocardial diabetic subject combined with cardiac autonomic neuropathy were behind the quietness of myocardial ischemia, known as silent myocardial ischemia (IMS). These patients have the risk to remain asymptomatic until the sudden onset of a myocardial infarction, or even sudden death. That is why the investigators want to evaluate the contribution of non-invasive tools to stand in the diagnosis of IMS patients with diabetes type 2, asymptomatic heart on map: Technical myocardial speckle tracking in studying strains overall average left ventricular (longitudinal, circumferential and radial) measured in 2D and 3D at rest, compared to stress echocardiography with dobutamine (ESD)

NCT ID: NCT02772887 Terminated - Type 2 Diabetes Clinical Trials

Nutraceutical Citrulline in Pregnancy

Start date: August 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if oral of L-citrulline (3 grams/day) for 3 weeks provided in mid-pregnancy to pregnant women with type 2 diabetes will increase the plasma L-arginine/ADMA ratio, lower maternal blood pressure and increase maternal levels of placental growth factor (PlGF).

NCT ID: NCT02721888 Terminated - Type 2 Diabetes Clinical Trials

Effect of Liraglutide on Fatty Liver Content and Lipoprotein Metabolism

LIRA-NAFLD/LIP
Start date: July 10, 2012
Phase: Phase 4
Study type: Interventional

Non-alcoholic fatty liver disease (NAFLD) is commonly associated with obesity, metabolic syndrome and type 2 diabetes. NAFLD, in patients with type 2 diabetes, has been shown to be associated with lipid abnormalities (such as hypertriglyceridemia and decreased HDL-cholesterol) and increased cardiovascular risk. Such lipid abnormalities (hypertriglyceridemia and decreased HDL-cholesterol) are very frequent in patients with type 2 diabetes. Moreover, NAFLD is a risk for further development of cirrhosis (estimated between 3 and 5%). Animal studies have shown that liraglutide is able to decrease liver fat content, but the effect of liraglutide on liver fat content in patients with diabetes remains unknown. In addition, human studies with liraglutide have shown significant modification of plasma lipids, such as reduction of plasma triglycerides and LDL-cholesterol. However, the mechanisms responsible for these liraglutide induced lipid modifications are not yet known. Because increased in liver fat content and hypertriglyceridemia are associated in patients with type 2 diabetes, it seems interesting to study the effect of liraglutide on both liver fat content and lipid metabolism using gold-standard methods (proton-spectroscopy for liver fat content assessment and kinetic study with stable isotope to study lipoprotein metabolism). This is a monocentric study. Fatty liver content will be performed by proton-spectroscopy in patients with type 2 diabetes (n=120) before and after a 6 month period of liraglutide therapy (1.2 mg/day). Moreover, an in vivo kinetic study will be performed with stable isotopes (13C leucine) in 10 patients among the 120 patients with type 2 diabetes (n=10) before and after a 6-month period of liraglutide (1.2 mg/day) therapy. Each kinetic study will be performed during a 2-day hospitalization For the main study, 3 visits will be performed: - a first visit at T0, before starting the treatment with liraglutide, including clinical and biological measurements and liver fat content assessment by proton-spectroscopy - a visit at 3 months including clinical and biological measurements - and a visit at 6 months including clinical and biological measurements and liver fat content assessment by proton-spectroscopy For the kinetic substudy, performed in 10 patients, a kinetic study with stable isotope will been performs during a 48h-hospitalization before starting the treatment with liraglutide and after 6 month-treatment with liraglutide

NCT ID: NCT02674893 Terminated - Type 2 Diabetes Clinical Trials

Effect of Victoza on Dietary Preferences and Habit in Patients With Type 2 Diabetes

GLP1 et Goût
Start date: February 4, 2014
Phase: Phase 4
Study type: Interventional

This is an open-label comparative study in three parallel groups. It is expected that 90 patients and/or healthy volunteers will participate in this biomedical research. Distribution in groups - 30 patients with type 2 diabetes and an indication for treatment with a GLP1 analogue (group 1) - 30 patients with type 2 diabetes (control diabetic subjects) not treated with Incretins (group 2) - 30 healthy subjects (non-diabetics) (group 3) This study will investigate modifications in eating behaviour induced by Liraglutide in patients who start treatment with Victoza® and certain aspects, such as liking (hedonic characteristic of a food), wanting (desire to eat a given food) and salivation in response to the presentation of a food by taking measurements at D0 (before initiation of the treatment with Liraglutide in the group concerned) then at 15 days (except for the controls), 3 months and 9 months (only for controls).

NCT ID: NCT02525263 Terminated - Type 2 Diabetes Clinical Trials

Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease (CKD)

RMCL-CL001
Start date: July 2016
Phase: Phase 2
Study type: Interventional

A Phase II, Open-Label Safety and Efficacy Study of an Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease (RMTX-CL001). NKA is made from expanded autologous selected renal cells (SRC) obtained from the patient's kidney biopsy. All enrolled subjects will be treated with up to two injections of NKA at least 6 months apart.

NCT ID: NCT02485132 Terminated - Type 2 Diabetes Clinical Trials

Evaluating the True Magnitude of HYPOglycemic Events After THE Initiation of Sulfonylurea

Start date: March 2016
Phase: N/A
Study type: Observational

Sulfonylurea are known to be associated with a risk of hypoglycaemia. However, little is known about the real frequency of asymptomatic or unreported hypoglycemia and their impact on glycemic control and quality of life among patients using sulfonylureas (SUs). The frequency of hypoglycemia is probably underestimated since self-monitoring of blood glucose (SMBG) fail to identify asymptomatic episodes, especially among patients with higher risk of hypoglycemia unawareness (longer diabetes duration, elderly, recurrent hypoglycemia, etc.). No previous studies have reported total hypoglycemia as measured by continuous glucose monitoring system (CGMS) in a large group of Canadians, therefore underestimating the true incidence of these events. As with age hypoglycemia perception is reduced and consequences can be increased due to frailty, elderly could be especially sensitive to the risk of hypoglycemia. Documentation of the total number of hypoglycemia is a relevant objective to really appreciate the potential impact of SUs in the Canadian context. The investigators propose a multicenter observational prospective study in order to study the incidence of hypoglycaemia measured by CGMS among patients with type 2 diabetes mellitus (T2DM) newly prescribed a SU. The investigators propose to perform a baseline testing (pre-initiation of the SU), at initiation (first week after the first dose of the SU) and after a 3 months follow-up of treatment, including medical history measures, quality of life and diabetes treatment satisfaction. In patients with T2DM not at goal (A1c >7.0 mmol/L), and newly prescribed a SU, the objectives and hypotheses of the study are to estimate the incidence rate of hypoglycaemia as measured by continuous glucose monitoring system (CGMS) over a total of 3 weeks period following the initiation of the SU.

NCT ID: NCT02443753 Terminated - Obesity Clinical Trials

EndoBarrier® SANS™ in Over-weight or Obese Type 2 Diabetic Subjects

Start date: May 2015
Phase: N/A
Study type: Interventional

This study will evaluate the safety and efficacy of the EndoBarrier® SANS™ in overweight and obese subjects with type 2 diabetes. The barbless second generation device is being developed as a means to reduce the incidence of adverse events associated with the barbs of the predicate device while maintaining a similar efficacy profile as measured by changes in weight and diabetic endpoints (HbA1c, blood glucose, insulin, etc.). This first use in human will primarily evaluate preliminary safety, tolerability and efficacy of the new design. Because of the new design and its first study in human subjects, only a 3 month implant duration will be evaluated in this study.